Kite Pharma is planning a “controlled” launch of its experimental CAR-T therapy that will likely rely on using medical experts to educate hospitals and cancer centers about the new technology.

The drugmaker recently pushed back the timeline for its plans to file an application for KTE-C19, its novel CAR-T cell therapy for diffuse large B-cell lymphoma, with the FDA in the beginning of 2017. The company had originally stated that it planned to file the drug with regulators before the end of the year.

CAR-T therapies are a form of personalized medicine — the treatment requires that a patient's cells are withdrawn, infused with an antigen, and then reinjected back into patients.

“This is not your grandfather's launch,” said Shawn Tomasello, chief commercial officer of Kite Pharma. “This is not like launching a small molecule or monoclonal antibody into the market.”

Kite and competing developers of CAR-T therapies including Juno Therapeutics and Novartis will be responsible for creating a market, and that will begin with enlisting hospitals and cancer centers that are already familiar with the treatment in what Tomasello said will be a “controlled but not limited launch.”

Communicating the value of this unique therapy will require new marketing tactics, according to experts. If KTE-C19 is approved by the FDA, it will represent a new challenge for the industry — namely, because the therapy is a significant departure from the usual monoclonal antibodies and small molecules that pharma is often charged with promoting and selling.

“Anytime you're getting ready to do something new and transformational you want the experience in the beginning to be positive,” Tomasello explained. “This goes past KTE-C19. There's going to be a learning curve and you want it to be a positive learning curve.”

PREPARING FOR LAUNCH

Kite plans to initially target institutions that are already familiar with the CAR-T administration process. The slow rollout of CAR-T is meant to be a form of quality control. That launch will target 72 institutions, including more than 40 clinical trial sites and 27 national cancer hospitals and national cancer care network centers.

Kite would be wise to ensure that the initial launch of KTE-C19 is successful, or it could repeat the mistakes of the last cell-based immunotherapy therapy that came to market — Dendreon's prostate cancer treatment Provenge — said ZS Associates principal Sharon Karlsberg. “They had manufacturing and supply issues, and they had limited supply at launch, so they couldn't make it available to everyone,” she explained.

Karlsberg said she would argue against a broad market development strategy for any CAR-T therapy and would instead start with cancer centers and clinical trial sites that are already familiar with the drug “to ensure acceptance of this complicated but promising new medical procedure.”

Lee Fraser, SVP, group director of science and medicine for pharmaceutical advertising agency Digitas Health LifeBrands, agrees with that approach. “We're not talking about medicine in the traditional sense,” he said “Scalability is something they need to lock down. They need to ramp up in a cautious and appropriate way. To ensure the best commercial experience, they should start with those who know [the process] in a controlled way. It's an appropriately cautious way to introduce something new.”

SALES AND CUSTOMER SUPPORT

Detailing, too, is expected to be markedly different for CAR-T therapies, Tomasello acknowledged. “There is no need for the old fashioned arms and legs race,” she said. “We can be a very targeted and efficient commercial team.”

She said that the company will use cell therapy account managers — most of whom will have medical backgrounds. Novartis, another CAR-T developer, has said that the company plans to approach detailing of its therapy similar to that of medical devices — where a sales representative functions like a resource to the physician, sitting in on surgeries and providing education and training.

Another commercial challenge will be providing customer support or beyond-the-pill services to both providers and patients. Karlsberg noted there needs to be appropriate infrastructure to ensure these medical procedures are successful and pointed out that Kite will need to employ the services of medical experts to support clinicians, nurses, and institutions.

To that end, Kite is launching KiteKonnect, a service meant to help connect patients and providers with appropriate resources, according to Tomasello. “It's about removing as much hassle and mystery as possible so patients can focus on their disease,” she said. “It's a way to genuinely partner with people in a way that matters.”

Specifically, the service is viewed as a way to help patients connect with third-party organizations, such as the ones that provide travel assistance to cancer patients, as well as help hospitals navigate reimbursement issues.

CREATING A VALUE PROPOSITION

These drugs are expected to be costly and Kite will be charged with proving that KTE-C19 is a better deal than the current standard of care for diffuse large B-cell lymphoma: a stem cell transplant, which according to a 2014 Milliman report can run between $378,000 to $930,000, depending on whether the stem cells come from the affected patient or from a donor.

During an investor presentation in early October, the company drew comparisons to three other oncology drugs: Celgene's Revlimid, Johnson & Johnson's Imbruvica, and Amgen's Blincyto, which annually run $300,000, $320,000, and $450,000, respectively, as a starting point for thinking about KTE-C19's potential price.

The drug's promising clinical data so far will also work in its favor — as well as payers' predisposition to covering oncology drugs — and as such the company may not face an uphill climb in ensuring access, said Karlsberg. “Historically, payers are less likely to restrict access to novel oncology treatments as well as the small number of patients that would likely receive the drug,” she said. Kite estimates that there are 7,400 patients with diffuse large B-cell lymphoma eligible for treatment with KTE-C19 in the U.S.

Tomasello said early discussions with payers have been encouraging and that company is leaning on its medical science liaisons to make the clinical case for KTE-C19.

But Karlsberg also said the company needs to be clear up front with payers about what exactly they're paying for. “Are you paying for a partial or complete response and do you compare that to ongoing treatment or progression?” she said. “How manufacturers define the total value proposition for CAR-T will be [crucial].”